FDA-Approval Does Not Ensure Safety or Effectiveness of Drugs

When a drug is approved by the U.S. Food and Drug Administration (FDA), it may give some the impression that it is proven to be safe and effective for a certain condition. An investigation by the Milwaukee Journal Sentinel, however, shows that this is not necessarily true. By focusing on new diabetes drugs that have been on the market, the investigation suggests that FDA approval is no guarantee of safety or efficacy.

Diabetes medications such as Januvia, Byetta and Victoza were linked to 3,000 deaths and about 20,000 hospitalizations in the last decade. Furthermore, the report showed that none of the 30 new diabetes drugs have been shown to decrease the risk of key complications associated with the condition, such as heart attacks, stroke and blindness.

What measures are being used to approve these drugs, then? Kearney Hub reports that a surrogate measure, a stand-in measure, is used in place of an eventual clinical outcome that is desired, such as saving lives. For instance, manufacturers may only have to show that diabetes drugs lower blood sugar to get approval; they do not actually have to prove that the drug prevents blindness or other complications.

The origin of surrogate measures stem from changes made to FDA rules two decades ago, when politicians and drug companies pushed for drugs to be on the market faster. There is a huge financial payoff for those in the diabetes drug business, with sales reaching $23 billion in 2013. To put this in perspective, Journal Sentinel says, this figure is larger than revenue from the National Football League, Major League Baseball and the National Basketball Association combined.

While some drugs offer real benefits for certain patients, others are marketed with questionable intent. Prescribing diabetes medications for patients who are so-called “pre-diabetic” is a prime example. “The trend to offer drugs to patients to delay a diagnosis of diabetes without making them healthier is a significant problem,” said Dr. Victor Montori, a diabetes expert at Mayo Clinic, to Kearney Hub. “Almost half of those included in the definition of patients with pre-diabetes won’t develop the disease in 10 years.”

Dr. Montori says that patients should speak with their doctors about whether or not a specific drug is actually necessary and whether or not there are other options. Looking at a drug’s “black-box” label is also important, as these are used to convey a serious or life-threatening complication. Patients should be aware of side effects and not brush them off, Kearney Hub says.

Another resource that patients can use is the website of http://dailymed.nlm.nih.gov/dailymed/index.cfmDailyMed, operated by the National Library of Medicine and the FDA, pharmacist Larry Sasich said to Kearney Hub. The site contains current product labels and medication guides for drugs that are associated with significant public health concerns.